Selected Ayurvedic Formulations in Gynecological Disorders: A Clinical Safety and Pharmacoepidemiological Perspective

Abstract

Background: Nowadays, safety of a drug is a major challenge than its efficacy. As the demand for Ayurvedic drugs is increasing day by day, the reporting of safety is essential.Objective: To review the clinical safety of Ayurvedic formulations, viz., Rajahpravartini vati Kanchanara Guggulu, Varunadi Kashaya, Ashokarishta, Ashvagandha Churna, and Pravala Pishti, which were trialed in 3 clinical trials on women's health to assess their efficacy and also clinical safety. Materials and methods:The analyzed data of 03 clinical studies on Kastartava (dysmenorrhea), menopausal syndrome, and polycystic ovary syndrome (PCOS) were collected from the Central Council for Research in Ayurvedic Sciences (CCRAS) database. These studies were conducted at 9, 3, and 2 centers on 359, 115, and 60 cases respectively, at the CCRAS institutes. The data have been critically evaluated to assay the clinical safety of the named six drugs trialed in these studies. All the studies were approved by the Institutional Ethics Committee conducted following the guidelines of good clinical practice. Written consent was obtained from the participants before their enrolment. Safety assessments were done by analyzing the laboratory parameters like liver function test and kidney function test before and after the trial periods. Paired sample t-test was used to compare the mean score. Any adverse drug reactions (ADRs) and side effects were also critically monitored. Results:In all the studies, it is observed that the safety laboratory parameters were within the normal range after drug administration in the participants, who were from different age groups, habitats, and prakriti. No cases of any ADR or drug intolerability were reported during the treatment period. Conclusion:From the results, it may be concluded that all the trial drugs are safe to use and can be used for a long period. Clinical significance:The results of the present study support the notion that if any Ayurvedic formulation has been manufactured as per good manufacturing practices (GMP) and administered at the recommended dose and duration, it is safe for human use.